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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 203534

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NDA 203534 describes IRBESARTAN, which is a drug marketed by Ajanta Pharma Ltd, Alembic Pharms Ltd, Amneal Pharms, Apotex Inc, Aurobindo Pharma Ltd, Chartwell Molecular, Chartwell Rx, Hetero Labs Ltd V, Hikma, Hisun Pharm Hangzhou, Ipca Labs Ltd, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, MSN, Prinston Inc, Sandoz, Sciegen Pharms Inc, Teva Pharms, Unichem, Watson Labs Inc, Yiling, Zydus Pharms Usa Inc, Alembic, Atlas Pharms Llc, Dr Reddys Labs Ltd, Pharmobedient, and Teva, and is included in thirty-eight NDAs. It is available from twenty-two suppliers. Additional details are available on the IRBESARTAN profile page.

The generic ingredient in IRBESARTAN is hydrochlorothiazide; irbesartan. There are thirty-two drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; irbesartan profile page.

Summary for 203534

Tradename:	IRBESARTAN
Applicant:	Jubilant Generics
Ingredient:	irbesartan
Patents:	0

Pharmacology for NDA: 203534

Mechanism of Action	Angiotensin 2 Receptor Antagonists

Suppliers and Packaging for NDA: 203534

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
IRBESARTAN	irbesartan	TABLET;ORAL	203534	ANDA	AvKARE	42291-940	42291-940-90	90 TABLET in 1 BOTTLE (42291-940-90)
IRBESARTAN	irbesartan	TABLET;ORAL	203534	ANDA	AvKARE	42291-941	42291-941-90	90 TABLET in 1 BOTTLE (42291-941-90)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	75MG
Approval Date:	Feb 23, 2015	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	150MG
Approval Date:	Feb 23, 2015	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	300MG
Approval Date:	Feb 23, 2015	TE:	AB	RLD:	No

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